PLAVIX SUMMARY
PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic events as follows:
- Recent MI, Recent Stroke or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
- Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
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NEWS HIGHLIGHTSMedia Articles Related to Plavix (Clopidogrel)
Giving Plavix Before Angioplasty May Cut Heart Attack Risk: Study
Source: MedicineNet clopidogrel Specialty [2012.12.19]
Title: Giving Plavix Before Angioplasty May Cut Heart Attack Risk: Study
Category: Health News
Created: 12/18/2012 4:36:00 PM
Last Editorial Review: 12/19/2012 12:00:00 AM
Adding Plavix to Aspirin Doesn't Help Guard Against Second Stroke: Study
Source: MedicineNet clopidogrel Specialty [2012.08.30]
Title: Adding Plavix to Aspirin Doesn't Help Guard Against Second Stroke: Study
Category: Health News
Created: 8/29/2012 6:05:00 PM
Last Editorial Review: 8/30/2012 12:00:00 AM
Aspirin as Good as Plavix for Poor Leg Circulation: Study
Source: MedicineNet Claudication Specialty [2012.02.22]
Title: Aspirin as Good as Plavix for Poor Leg Circulation: Study
Category: Health News
Created: 2/21/2012 6:05:00 PM
Last Editorial Review: 2/22/2012 12:00:00 AM
Published Studies Related to Plavix (Clopidogrel)
Clopidogrel trial in patients with elective percutaneous coronary intervention
for stable angina and old myocardial infarction (CLEAN). [2012]
Clopidogrel in combination with aspirin has been widely used in patients who have
undergone coronary stent implantation. However, the benefit to Japanese patients
with stable angina (SA) or old myocardial infarction (OMI) undergoing
percutaneous coronary intervention (PCI) still remains unclear.The aim of this
multicenter, randomized, double-blind, clinical study was to evaluate the safety
of a clopidogrel 300 mg loading dose followed by a 75 mg maintenance dose
compared to ticlopidine 100 mg twice daily in patients with SA or OMI undergoing
PCI who were on aspirin (81 to 100 mg once daily)...
Association of proton pump inhibitor use on cardiovascular outcomes with
clopidogrel and ticagrelor: insights from the platelet inhibition and patient
outcomes trial. [2012]
CONCLUSIONS: The use of a PPI was independently associated with a higher rate of
Reversal of clopidogrel-induced bleeding with rFVIIa in healthy subjects: a randomized, placebo-controlled, double-blind, exploratory study. [2011.10]
BACKGROUND: Clopidogrel (Plavix(R)) therapy, although effective for minimizing risk of thrombotic events, is also associated with potential bleeding risk. Recombinant activated FVII (rFVIIa, NovoSeven(R)) induces hemostasis in hemophilia patients with inhibitors (alloantibodies) and has been proposed as potential treatment for mitigating clopidogrel therapy-mediated bleeding... CONCLUSIONS: In this clinical study, rFVIIa (10 and 20 mug/kg) reversed the effect of clopidogrel on blood loss.
Effect of clopidogrel withdrawal on platelet reactivity and vascular inflammatory biomarkers 1 year after drug-eluting stent implantation: results of the prospective, single-centre CESSATION study. [2011.10]
CONCLUSION: An aspirin-independent, time-dependent increase in AA-induced platelet activation following clopidogrel withdrawal in patients with a DES has been described. New insights into a potential mechanism for the observed clustering of adverse events that occur early after clopidogrel cessation have been provided. These findings raise the question as to whether AA-induced clotting is an appropriate test of aspirin sensitivity.
Variability in response to clopidogrel: how important are pharmacogenetics and drug interactions? [2011.10]
Clopidogrel is a pro-drug which is converted to an active metabolite that selectively blocks ADP-dependent platelet activation and aggregation. The main enzyme responsible for activating clopidogrel is the cytochrome P450 (CYP) isoenzyme CYP2C19, which is polymorphic... This current review aims to summarize the role of pharmacogenetics and drug interactions in determining variability in response to clopidogrel.
Clinical Trials Related to Plavix (Clopidogrel)
Pharmacodynamics of CGT 2168 Compared With Plavix® [Active, not recruiting]
CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to
characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose
combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix®
(clopidogrel, 75 mg).
Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period,
subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix®
in the order determined by the randomization schedule. Each period of dose administration
will be separated by a two-week washout period. Study exit will occur 1 week after Dosing
Period 2. The expected total duration of participation is 8 weeks (56 days), including a
screening visit on or within 21 days prior to enrollment.
On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the
Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected
pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent
and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and
pre-dose and serially after dosing on Day 7.
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function [Completed]
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces
peri-procedural and long-term ischemic complications. Documented reduced response to
clopidogrel has been associated with subsequent major adverse cardiovascular events.
Strategies to optimize platelet inhibition pre-PCI are under investigation.
This study sought to evaluate the effect on platelet aggregation of four different dosing
regimens of clopidogrel given before elective PCI.
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS [Completed]
Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in
patients with coronary artery disease. In the proposed study we wish to prospectively assess
the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with
clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients
who demonstrate non-responsiveness to clopidogrel.
Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel
bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a
single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel
bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a
single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.
Reports of Suspected Plavix (Clopidogrel) Side Effects
Death (186),
Gastrointestinal Haemorrhage (126),
Dyspnoea (115),
Anaemia (109),
Myocardial Infarction (104),
Contusion (90),
Haemorrhage (74),
Asthenia (72),
Fall (70),
Cerebrovascular Accident (68), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Plavix has an overall score of 7.75. The effectiveness score is 8.50 and the side effect score is 8.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Plavix review by 65 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | R.A. |
| Dosage & duration: | | 200 mg taken twice per day for the period of 7 yrs. |
| Other conditions: | | None |
| Other drugs taken: | | Meloxicam 7.5 mg (Mobic) | | |
Reported Results |
| Benefits: | | This regimen eliminated, for the most part, the pain, stiffness, and exhaustion experienced with rheumatoid arthritis. |
| Side effects: | | No side effects at all, other than returning me to an apparently more normal state of health. |
| Comments: | | Initially, stronger drugs such as cortisone were needed to control and stabilize the rheumatoid arthritis. Once that was accomplished, the Plavix/Mobic treatment has been consistently effective for quite a few years. |
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| | Plavix review by 59 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | strokes |
| Dosage & duration: | | 75mg taken 1 per day for the period of About 5 years and continuing |
| Other conditions: | | high bad cholesterol, elevated blood pressure |
| Other drugs taken: | | ramapril, lipitor | | |
Reported Results |
| Benefits: | | Since starting the plavix and other meds, I have had no strokes. |
| Side effects: | | Terrible bruising. If I bump my fingers, the joints will swell. |
| Comments: | | I've had one stroke and 15 T.I.A.s. It is a genetic problem, but I have fully recovered from all. The first was in my 30's. I eat a very healthy, low fat, vegetarian diet and I excercise regularily. The meds I take are necessary, however a healthy, acitve lifestyle is critical. |
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| | Plavix review by 59 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | strokes |
| Dosage & duration: | | 75mg taken 1 per day for the period of About 5 years and continuing |
| Other conditions: | | high bad cholesterol, elevated blood pressure |
| Other drugs taken: | | ramapril, lipitor | | |
Reported Results |
| Benefits: | | Since starting the plavix and other meds, I have had no strokes. |
| Side effects: | | Terrible bruising. If I bump my fingers, the joints will swell. |
| Comments: | | I've had one stroke and 15 T.I.A.s. It is a genetic problem, but I have fully recovered from all. The first was in my 30's. I eat a very healthy, low fat, vegetarian diet and I excercise regularily. The meds I take are necessary, however a healthy, acitve lifestyle is critical. |
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Page last updated: 2013-02-10
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